FDA Approves New Therapies and Expands Indications in Gastroenterology
Key Insights
The FDA approved Gilead’s Livdelzi for primary biliary cholangitis (search) treatment, offering a new option for patients inadequately responding to or intolerant of UDCA.
Skyrizi gained FDA approval for moderate to severe ulcerative colitis (search), marking it as the first IL-23 inhibitor approved for both UC and Crohn’s disease (search).
Tremfya was approved for moderately to severely active ulcerative colitis (search), joining Skyrizi in the increasingly competitive UC treatment landscape.
Following a surge of FDA approvals in gastroenterology, including the first blood test for colorectal cancer (search), the agency has continued to greenlight new therapies and expand indications for existing drugs. These approvals and designations address unmet needs in various gastrointestinal and liver diseases, offering new hope for patients.
Livdelzi Approved for Primary Biliary Cholangitis
Gilead's Livdelzi (seladelpar), a selective peroxisome proliferator-activated receptor delta agonist, received accelerated FDA approval for treating primary biliary cholangitis (search) (PBC). The approval covers use in combination with ursodeoxycholic acid (UDCA) for adults with inadequate response to UDCA, or as monotherapy for those intolerant to UDCA. PBC is a chronic liver disease that damages the bile ducts, leading to liver damage. Livdelzi offers a novel approach by targeting a key regulator of bile acid metabolism.
Skyrizi Approved for Ulcerative Colitis
AbbVie (search)'s Skyrizi (risankizumab) has been approved by the FDA for treating adult patients with moderate to severe ulcerative colitis (search) (UC). This approval marks Skyrizi as the first interleukin-23 (IL-23) specific inhibitor approved for both UC and Crohn's disease. The approval was supported by clinical trial data demonstrating significant improvements in clinical remission and endoscopic improvement. Skyrizi is now approved for four indications across immune-mediated inflammatory diseases, including inflammatory bowel disease (IBD), plaque psoriasis, and psoriatic arthritis.
Tremfya Approved for Ulcerative Colitis
Johnson & Johnson’s Tremfya (guselkumab), a dual acting interleukin-23 inhibitor, has secured FDA approval for the treatment of patients with moderately to severely active ulcerative colitis (search). This approval positions Tremfya as a new contender in the increasingly crowded UC market, competing with AbbVie (search)'s Skyrizi. Tremfya is now approved for three indications including plaque psoriasis, active psoriatic arthritis and UC.
Plozasiran Receives Breakthrough Therapy Designation for FCS
The FDA has granted breakthrough therapy designation to Arrowhead Pharmaceuticals’ plozasiran, when coupled with diet, to decrease triglycerides in patients with familial chylomicronemia syndrome (search) (FCS). FCS is a rare genetic hyperlipidemia characterized by extremely elevated triglyceride levels, increasing the risk of acute pancreatitis, abdominal pain, diabetes, and hepatic steatosis. Plozasiran, a first-in-class investigational RNA interference therapeutic, inhibits the production of apolipoprotein C-III (search), reducing triglycerides and returning lipids to normal levels.